Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Phase 4

• Conditions: Type II Diabetes Mellitus
• Interventions: Procedure: sleeve gastrectomy; Procedure: gastric bypass

• Registration Number: NCT00540462
• Lead Sponsor: Min-Sheng General Hospital

Brief Summary

Although intensive medical treatment of diabetes has clearly been demonstrated to be worthwhile, it has not been a total success in diabetes treatment for a variety of reasons including lack of response to medication. Diabetes has been well demonstrated as a co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base of this observation, we will try to find out the role surgical intervention (gastric bypass \& sleeve gastrectomy) in obese-related diabetes.

Detailed Description

In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base on this observation, we will try to find out the role surgical intervention (gastric bypass and sleeve gastrectomy) in obese-related diabetes. With restriction of stomach volume and with or without duodenal exclusion, this randomized trials will find out the role of duodenal exclusion and the role of Ghrenin in obese-related type II DM patients. The initial observation of previous morbidly obese patients with type II DM, the DM seems a chronic disease which could be treated or controlled by surgical intervention, that's what we try to know more.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2008-08
• Status Verified: 2008-10
• Last Update Submitted: 2008-11-13
• Last Update Posted: 2008-11-14
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient with diagnosis of T2DM for at least 6 months
• Mild to moderate obesity status(BMI 27 - 35 )
• Age : 30 - 60 year-old
• HbA1C > 8 %

Exclusion Criteria

• With co-morbidity illness of cardiovascular system
• DM related nephropathy (Cre >2.0 mg/dl)
• Pulmonary embolism or uncontrolled coagulopathy in 6 months
• HBV or HCV hepatitis or liver cirrhosis, inflammatory colon disease, Cushing syndrome
• s/p organ transplantation
• Previously Bariatric surgery, gastrointestinal surgery, or abdominal sepsis
• Alcoholic or drug abuser
• Psychological disease.
• HIV or TB patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	sleeve gastrectomy	Sugical Group with Sleeve gastrectomy
2	gastric bypass	Surgical Group with gastric bypass

Primary Outcome Measures

Name	Time	Method
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.	1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months

Secondary Outcome Measures

Name	Time	Method
Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy	1 yr

Trial Locations

Locations (1)

MinSheng Genral Hospital; 🇨🇳 Taoyuan, Taiwan